Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome

This is a randomized, single blinded, non-placebo controlled that will compare one group of Bells Palsy patients receiving the current standard of care including oral corticosteroids and oral antivirals against an experimental group receiving the current standard of care in addition to hyperbaric oxygen therapy. Outcome assessment will be based on both objective analyses of facial movements as well as subjective quality of life scales.

Study Overview

• Status: Withdrawn
• Conditions: Bell Palsy
• Intervention / Treatment: Drug: Oral Corticosteroids; Drug: Oral antivirals; Device: Hyperbaric Oxygen Therapy

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years or older exhibiting unilateral facial paralysis progressing to completion in 4 days or less.

Exclusion Criteria:

• No patients from vulnerable populations as listed above will be included.
• Subjects must be able to travel to NYULMC continually during the first 12 months following enrollment.
• During the initial visit candidates must have no associated clinical signs or symptoms consistent with other causes of facial palsy. This includes but is not limited to: auricular papules, skin rashes, parotid masses, craniofacial trauma, and the presence of other cranial or distal neuropathies excluding facial numbness, change in taste, and/or hyperacusis.
• Patients with atypical presentations will be referred for cross-sectional imaging and excluded.
• Patients with histories consistent with possible recent tick exposure, rashes, headaches, or excessive fatigue will be serologically tested for Lyme disease and excluded if it returns positive.
• Pneumothorax within the last two years is the only absolute medical exclusion criteria (FF).
• Patients who are epileptics, or are claustrophobic, will be carefully counseled on the risks of HBOT before being allowed to enroll.
• Patients with severe comorbidities will undergo evaluation by their primary care doctor and require physician approval prior to enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care Therapy; Reference Therapy	Drug: Oral Corticosteroids; Prednisone 10 day taper: 60mg for 5 days, then taper for five days to 0mg; Drug: Oral antivirals; acyclovir 400mg: one pill 4 times daily for 7 days
Experimental: Standard of Care + HOTB; Reference therapy in addition to Hyperbaric Oxygen Therapy	Drug: Oral Corticosteroids; Prednisone 10 day taper: 60mg for 5 days, then taper for five days to 0mg; Drug: Oral antivirals; acyclovir 400mg: one pill 4 times daily for 7 days; Device: Hyperbaric Oxygen Therapy; 2.4atm administered for twice daily dives for 5 days, 10 dives total. To be begun in the first 1 week after onset of paralysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care Group	3, 6 and 12 months
Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care + Hyperbaric Oxygen Therapy on Bells Palsy (HBOT) Group	3, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form 36 (SF-36) Score Standard of Care Group	As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36). The eight sections are: vitality physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health	3, 6 and 12 months
Short Form 36 (SF-36) Score Standard of Care + HBOT	As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36). The eight sections are: vitality physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health	3, 6 and 12 months
Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care Group	Used to assess facial impairment and disability after facial paralysis. It involves 15 statements, each using a five-item Likert scale. A participant circles the most appropriate response to a given statement, whereby 1 corresponds to the lowest function and 5 corresponds to the highest function. Statements are grouped into six independent domains: social function, facial movement, facial comfort, oral function, eye comfort, and lacrimal control. A score from 0 (worst) to 100 (best) is calculated.	3, 6 and 12 months
Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care + HBOT	Used to assess facial impairment and disability after facial paralysis. It involves 15 statements, each using a five-item Likert scale. A participant circles the most appropriate response to a given statement, whereby 1 corresponds to the lowest function and 5 corresponds to the highest function. Statements are grouped into six independent domains: social function, facial movement, facial comfort, oral function, eye comfort, and lacrimal control. A score from 0 (worst) to 100 (best) is calculated.	3, 6 and 12 months
Facial Disability Index (FDI) Score Standard of Care Group	Assesses facial neuromuscular dysfunction. Consists of 10 questions regarding physical function scoring difficulty on a scale of 2-5; 5 being "no difficulty" and 2 being "much difficulty"	3, 6 and 12 months
Facial Disability Index (FDI) Score Standard of Care + HBOT	Assesses facial neuromuscular dysfunction. Consists of 10 questions regarding physical function scoring difficulty on a scale of 2-5; 5 being "no difficulty" and 2 being "much difficulty"	3, 6 and 12 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Jeffrey Markey, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Oxygen Therapy; Bells Palsy
• Additional Relevant MeSH Terms: Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Facial Nerve Diseases; Paralysis; Bell Palsy; Facial Paralysis; Anti-Infective Agents; Antiviral Agents
• Other Study ID Numbers: 17-01740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Only as pertains to study results, will be shared only during publication.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Only shared with publication.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes